Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.
This is a global, prospective, multi-center study with a planned analysis of a minimum of 176 Subjects. Up to 15 study sites will participate in this study. The primary and secondary endpoints are as follows: Primary endpoint: The primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan. Secondary endpoints: 1. Inclination success (as defined for the primary endpoint) 2. Version success (as defined for the primary endpoint) 3. 90-day complication rates 4. Change from preoperative baseline for the Harris Hip Score 5. Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral) 6. Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable) 7. Change from 6 week baseline for the Forgotten Joint Score
Study Type
OBSERVATIONAL
Enrollment
183
The study devices are the Pinnacle Hip System acetabular cup with a Summit, Actis, or Corail femoral stem
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States
Mount Sinai Hospital
New York, New York, United States
Carolina Orthopaedic and Sports Medicine Center
Gastonia, North Carolina, United States
Composite success of cup inclination and cup version.
The primary endpoint is acetabular cup position success at 6 weeks postoperatively. It is a composite endpoint; in order for an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks: 1. Inclination Success: within 10 degrees of the planned inclination 2. Version Success: within 10 degrees of the planned version
Time frame: 6 weeks
Inclination success
Inclination Success: within 10 degrees of the planned inclination
Time frame: 6 weeks
Version success
Version success: within 10 degrees of the planned version
Time frame: 6 weeks
90 day postoperative complication rates
The number of subjects and the percentage of subjects with complications at 90 days post-operatively
Time frame: 90 days postoperative
Harris Hip Score
Change from preoperative baseline for the Harris Hip Score
Time frame: Baseline and 6 and 12 weeks postoperative
Forgotten Joint Score
Change from 6 week baseline for the Forgotten Joint Score
Time frame: 6 and 12 weeks postoperative
EQ-5D-5L dimension score
Mean change from baseline for the specified time points
Time frame: Baseline and 6 and 12 weeks postoperative
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Orthopedic Specialists and Sports Medicine
Newark, Ohio, United States
Lowcountry Orthopaedics & Sports Medicine
Charleston, South Carolina, United States
Istituto Orthopedico Galeazzi IRCCS
Milan, Italy
Bravis Hospital
Bergen op Zoom, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Netherlands
Woodend Hospital
Aberdeen, Scotland, United Kingdom
...and 1 more locations
EQ-VAS score (subscore of EQ-5D-5L)
Mean change from baseline for the specified time points
Time frame: Baseline and 6 and 12 weeks postoperative
EQ-5D-5L index value (if applicable)
Mean change from baseline for the specified time points
Time frame: Baseline and 6 and 12 weeks postoperative
Radiographic Outcomes
Radiographs will be read by an independent radiographic reviewer (IRR) at 6 weeks to act as a baseline measurement to be compared to radiographs taken at later time points (12 weeks). Parameters measured include subsidence, migration, inclination and version angles, osteolysis, and radiolucency.
Time frame: Baseline and 6 and 12 weeks postoperative